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NCT01849003 · ClinicalTrials.gov registry record · Phase 1
Study of the Effect of GS-6615 in Subjects With LQT-3
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01849003: Completed Phase 1 study, sponsored by Gilead Sciences.
NCT01849003 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849003, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This mechanism of action study is to evaluate the effect of oral GS-6615 on the QTc interval in participants with Long QT-3 syndrome. This study will be performed in six cohorts of participants in a sequential manner, four single-dose cohorts followed by two multiple-dose cohorts. Duration of treatment for the single-dose cohorts and multiple-dose cohorts will be 1 day and 7 days, respectively. Participants will be confined at the study center from check-in until completion of assessments at discharge. Participants will be continuously monitored using real-time telemetry throughout the in-clinic confinement. Physical examinations including vital signs, laboratory analysis, electrocardiograms (ECGs), Holter recordings and echocardiography (ECHO) will be performed at defined time points throughout the study period. Assessment of adverse events and concomitant medications will continue throughout the duration of the study.
Primary Outcome
Changes in QTc intervals (Fridericia formula; QTcF) from the time-matched ECG in the primary lead V5. In case QT cannot be measured in lead V5, lead II will be designated as the primary lead * Change from the time-matched ECG on Day -1 to Day 1 for Cohorts 1-4 * Change from the time-matched ECG average of Day -1 and Day -2 to Days 1-7 for Cohort 5 and 6
Interventions
- DRUG GS-6615
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01849003 record still lists
NCT01849003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which GS-6615 is the first listed.
NCT01849003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01849003 about?
NCT01849003 is a clinical study titled "Study of the Effect of GS-6615 in Subjects With LQT-3". This mechanism of action study is to evaluate the effect of oral GS-6615 on the QTc interval in participants with Long QT-3 syndrome. This study will be performed in six cohorts of participants in a sequential manner, four single-dose cohorts followed by two multiple-dose cohorts. Duration of treatm...
What is the current status of trial NCT01849003?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-05. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01849003?
The interventions under investigation include: GS-6615 (DRUG).
Who is sponsoring clinical trial NCT01849003?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01849003's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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